Babi — Class I medical device recall Z-0009-2020
Terminated recall by TELEFLEX-MORRISVILLE, reported 2019-11-13, distributed nationwide. Device vented gas below the stated pressure.
| Recall number | Z-0009-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TELEFLEX-MORRISVILLE, Morrisville, NC, United States |
| Recall initiated | 2019-06-14 |
| Classified | 2019-11-06 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2024-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 9,312 units |
| Lot numbers | 180806, 180910, 181029, 181105, 181204, 190225, 190327 |
| Model numbers | 2691 |
Product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Reason for recall
Device vented gas below the stated pressure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0009-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.